Penn’s Immunotherapy for Leukemia Receives FDA’s Breakthrough Designation


July 8, 2014

The U.S. Food and Drug Administration awarded the University of Pennsylvania's personalized immunotherapy—known as CTL019—its Breakthrough Therapy Designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia (ALL), reports the Wall Street Journal and Reuters. Such a designation expedites the development and review of new medicines that treat serious or life-threatening conditions. "Receiving the FDA's Breakthrough Designation is an essential step in our work with Novartis to expand this therapy to patients across the world who desperately need new options to help them fight this disease," said Carl June, MD, the Richard W. Vague Professor in Immunotherapy and director of Translational Research in the Abramson Cancer Center. CTL019 is the first personalized cellular therapy for the treatment of cancer to receive this important classification. The announcement was also covered by Agence France-Presse, the Philadelphia Business Journal, and Fierce Biotech.

Penn Medicine news release
Wall Street Journal article
Reuters article
Agence France-Presse article via Yahoo News
Philadelphia Business Journal article
Fierce Biotech article